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A Patient’s Guide To Advanced,

Minimally-Invasive Treatment Of
Venous Thromboembolism (VTE)

How Ultrasonic
Sound Waves Can
Help Safely Dissolve
Blood Clots
Venous Thromboembolism (VTE) is a serious
and potentially life threatening condition that includes both
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
DVT occurs when a blood clot forms in one of the deep veins
in your body, limiting blood flow. It usually occurs in your leg
or pelvis, but it can also occur in your arm or chest.
There are several reasons to seek immediate treatment
for DVT. There is a risk that a portion of the clot could break
off and travel to your lungs, blocking the blood flow and
damaging your heart and lungs. This condition, called
Pulmonary Embolism, can be fatal within a few hours.
There are also long-term consequences of upper leg
DVT. If the clot isn’t dissolved within a few weeks, it becomes
a Chronic Deep Vein Thrombosis. The old blood clot can
permanently damage the valves in your veins creating a
condition called Post-
Thrombotic Syndrome (PTS).
Symptoms Of DVT An estimated 50 percent of
patients with chronic DVT in
Symptoms include: the upper leg area may
• Redness or skin discoloration develop PTS, which can cause
• Calf or leg pain or tenderness, disability and negatively
especially when walking or standing
impact your quality of life.1,2,3
• Swelling of the affected body part
• Sensation of warmth
• Leg fatigue

1. Kahn, S et al. Relationship between Deep Venous Thrombosis and the Post-Thrombotic
Syndrome. Arch Intern Med 2004; 164:17-26.
2. Ashrani AA, Heit JA. Incidence and cost burden of post-thrombotic syndrome. J Thromb
Thrombolysis. 2009;28::465-476.
3. Kahn, S. et al. Determinants and Time Course of the Post-thrombotic Syndrome After
Acute Deep Venous Thrombosis. Annals of Internal Medicine, 149, 2008, 698–707.
Dissolving The Clot At
An Early Stage May Reduce
The Risk Of Complications
When a person develops a Deep Vein Thrombosis (DVT), there
is a window of opportunity in which the clot can be dissolved and
normal blood flow restored. Dissolving the clot reduces the short-
term risk of a pulmonary embolism (from a piece of clot breaking
off and traveling to the lungs). It also reduces the long-term risk
of developing Post-Thrombotic Syndrome. A minimally invasive
system for dissolving thrombus using ultrasonic technology is
now available.
Until recently, the routine treatment for DVT was
anticoagulation therapy (blood thinning drugs). These drugs
are used to prevent a clot from getting bigger and to lessen
the possibility that a piece of the clot will break off, causing a
pulmonary embolism. They are also used to reduce the risk of
future clots.
However, anticoagulants do not actively dissolve the clot,
nor can they restore blood
September 2008 flow to the vein. So while they
reduce the risk of pulmonary
U.S. Surgeon General’s
embolism, they can’t
“Call to Action” eliminate it.
Frequently the clot will
The Surgeon General has announced a Call To
Action to Prevent Deep Vein Thrombosis (DVT) harden, potentially damaging
and Pumonary Embolism (PE). The goal is to both the vein and the valves
create greater awareness and the development that regulate blood flow.
of evidence based practices through education When this happens, the
of the consumer and healthcare providers on patient may develop the
the screening, symptoms, prevention, diagnosis
chronic complications
and treatment of DVT and PE.
associated with Post-
www.ncbi.nlm.nih.gov/books/NBK44178/ Thrombotic Syndrome.
Minimally-Invasive Treatment Can
Dissolve Clots And Restore Function
Acoustic Pulse Thrombolysis™ treatment uses ultrasonic
waves in combination with clot-dissolving drugs to dissolve a
clot, reducing the risk of both pulmonary embolism and long-
term side effects. The biochemistry involved is similar to that of
the human body’s actual process in dissolving clot.
The procedure, which is usually done in a hospital, is
minimally invasive and does not require general anesthesia. A
special catheter (long, flexible tube) is inserted into a vein.
Using image-guided technology, the doctor gently threads the
catheter to the clot. (Because there are no nerve cells in blood
vessels, there is no sensation of the catheter moving.)
Inside the specialized catheter are low-power micro-
transducers. Once the catheter is
in place, the system will transmit
low power, high-frequency sound What is
waves into the clot. Post-Thrombotic
The ultrasonic energy Syndrome?
loosens the tightly bound clot
and, at the same time, forces When a clot remains in the leg, it can cause
clot-dissolving drugs deep irreversible damage to the veins and its
valves. The damaged valves don’t open
inside the clot. The combination
and close properly, allowing the blood to
of the sound waves and the pool in the legs. The condition, known as
drugs gently dissolves the clot Post-Thrombotic Syndrome (PTS), is often
without breaking it apart. debilitating with patients experiencing:

• Chronic pain
• Swelling
• Skin ulcerations
• Varicose Veins
The pooled blood also makes the patient
more prone to develop another DVT and
increases their risk for pulmonary embolism.
Like a tightly wound ball
of string, a clot can be
difficult to penetrate.
Ultrasonic sound waves
gently loosen the Tightly bound fibrin
fibers that hold the clot
together and push clot-
dissolving drugs inside.
The clot quickly and
gently dissolves away.

Loosened fibrin

What You Should Know Before Choosing


Acoustic Pulse Thrombolysis™ Treatment
This treatment for DVT is most effective when the
clot is relatively new, usually when you have had
symptoms for less than 30 days.
Because this treatment uses clot-dissolving drugs,
there is a risk of bleeding. So if you have a history of
bleeding or blood disorders, it may not be appropriate for
you. You should also not have this procedure if you have
high blood pressure that is difficult to control or have
sensitivities to contrast agents used in imaging studies.
Afterwards, you may still need to take blood thinners
to assure another clot does not form. You may also need
additional treatment to address the underlying causes of
the clot. Your doctor will talk with you about other risks
associated with this procedure.
Indications and Safety Information
FDA CLEARED INDICATIONS: The EkoSonic® Endovascular System is
indicated for the ultrasound facilitated, controlled and selective infusion
of physician-specified fluids, including thrombolytics, into the vasculature
for the treatment of pulmonary embolism; the controlled and selective
infusion of physician-specified fluids, including thrombolytics, into the
peripheral vasculature; and the infusion of solutions into the pulmonary
arteries. Caution: Federal (USA) law restricts these devices to sale by or
on the order of a physician.

Potential Adverse Events - Potential adverse events (in alphabetical


order) which may be associated with use of the system are similar to
those associated with other interventional procedures and include but
are not limited to the following: air embolism, allergic reaction to contrast
medium, amputation, arteriovenous fistula, bleeding from access site,
death, dissection, distal embolization of blood clots, drug reaction,
hematoma, hemolysis, hemorrhage requiring transfusion, hypotension/
hypertension, infection at access site, pain and tenderness, perforation,
pseudo aneurysm, total occlusion of treated vessel, vascular spasm,
vascular thrombosis, vessel wall or valve damage.

EKOS® and EkoSonic® are registered trademarks of EKOS Corporation,


a BTG International group company. ‘Acoustic Pulse Thrombolysis’
is a trademark of EKOS Corporation. ‘Imagine where we can go’ is a
trademark of BTG International Ltd. BTG and the BTG roundel logo are
registered trademarks of BTG International Ltd in US, EU and certain
other territories and trademarks of BTG International Ltd elsewhere.

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